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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125249
Company: KINIKSA PHARMACEUTICALS (UK), LTD.

Products on BLA 125249

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARCALYST	RILONACEPT	220MG	VIAL; SINGLE-USE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2008	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125249s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125249s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2021	SUPPL-49	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125249Orig1s049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/125249Orig1s049.pdf
12/18/2020	SUPPL-47	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s047ltr.pdf
02/12/2020	SUPPL-45	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s045ltr.pdf
09/30/2010	SUPPL-18	Supplement		Label is not available on this site.

Labels for BLA 125249

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2021	SUPPL-49	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf
12/18/2020	SUPPL-47	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf
02/12/2020	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf
02/27/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf

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